Teicoplanin Aptapharma

Leaflet accompanying the packaging: information for the user

Teicoplanin AptaPharma, 200 mg,

powder and solvent for solution for injection/infusion

Teicoplanin AptaPharma, 400 mg, powder and solvent for solution for injection/infusion

Teicoplanin
Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Teicoplanin AptaPharma and what is it used for
• 2. Important information before using Teicoplanin AptaPharma
• 3. How to use Teicoplanin AptaPharma
• 4. Possible side effects
• 5. How to store Teicoplanin AptaPharma
• 6. Contents of the packaging and other information

1. What is Teicoplanin AptaPharma and what is it used for

Teicoplanin AptaPharma is an antibiotic. It contains the active substance teicoplanin. It works by killing the bacteria that cause the infection in the patient's body.
Teicoplanin AptaPharma is used in adults and children (including newborns) to treat bacterial infections:

• of the skin and subcutaneous tissue - sometimes called "soft tissue"
• of bones and joints
• of the lungs
• of the urinary tract
• of the heart - sometimes called "endocarditis"
• of the subcutaneous tissue of the abdomen - peritonitis
• of the blood, if caused by any of the above-mentioned health conditions.

Teicoplanin AptaPharma can be used to treat some infections caused by Clostridium difficilebacteria in the intestines. For this purpose, the solution of the medicine is taken orally.

2. Important information before using Teicoplanin AptaPharma

When not to use Teicoplanin AptaPharma

• if the patient is allergic to teicoplanin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Teicoplanin AptaPharma, the patient should discuss with their doctor, pharmacist, or nurse if:

• the patient is allergic to an antibiotic called "vancomycin"
• the patient has experienced redness of the upper body ("red man syndrome")
• the patient has a reduced platelet count (thrombocytopenia)
• the patient has kidney problems
• the patient is taking other medicines that may cause hearing or kidney problems. The patient may need to undergo regular tests to check if their kidneys and/or liver are working properly (see "Teicoplanin AptaPharma and other medicines").

If any of the above conditions apply to the patient (or the patient is unsure), they should consult their doctor, pharmacist, or nurse before taking Teicoplanin AptaPharma.
During treatment with teicoplanin, severe skin reactions have been reported, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).
If the patient experiences a severe rash or other skin symptoms described in section 4, they should stop using Teicoplanin AptaPharma and seek medical attention immediately.

Diagnostic tests

During treatment, the patient may undergo blood tests, kidney function tests, liver function tests, and/or hearing tests. This is more likely if:

• treatment will last for a long time
• the patient will be treated with high loading doses (12 mg/kg twice a day)
• the patient has kidney problems
• the patient is taking or may take other medicines that may affect the nervous system, kidneys, or hearing.

In patients taking Teicoplanin AptaPharma for a long time, there may be a greater than usual increase in bacteria that the antibiotic does not affect. The doctor will check this.

Teicoplanin AptaPharma and other medicines

The patient should tell their doctor, pharmacist, or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
This is because Teicoplanin AptaPharma may affect the action of other medicines. Also, some medicines may affect the action of Teicoplanin AptaPharma.
In particular, the patient should tell their doctor, pharmacist, or nurse if they are taking any of the following medicines:

• aminoglycosides - because they should not be mixed with Teicoplanin AptaPharma in the same injection. These medicines may also cause hearing or kidney problems.
• amphotericin B - a medicine used to treat fungal infections, which may cause hearing or kidney problems.
• cyclosporin - a medicine that affects the immune system, which may cause hearing or kidney problems.
• cisplatin - a medicine used to treat cancer, which may cause hearing or kidney problems.
• diuretics (such as furosemide) - also known as "water pills", which may cause hearing or kidney problems.

If any of the above conditions apply to the patient (or the patient is unsure), they should consult their doctor, pharmacist, or nurse before taking Teicoplanin AptaPharma.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, thinks they may be pregnant, or plans to have a child, they should consult their doctor, pharmacist, or nurse before using this medicine. They will decide whether the medicine can be given to the patient during pregnancy. There is a risk of damage to the inner ear and kidney problems.
If the patient is breastfeeding, they should tell their doctor before taking this medicine. The doctor will decide whether the patient can breastfeed while taking Teicoplanin AptaPharma.
Studies on the effect on fertility conducted in animals did not show any evidence of fertility disorders.

Driving and using machines

During treatment with Teicoplanin AptaPharma, the patient may experience pain or dizziness.
If the patient experiences such symptoms, they should not drive vehicles, operate any tools, or machines.

Teicoplanin AptaPharma contains sodium:

The medicine contains 10 mg of sodium (the main component of common salt) in each vial. This corresponds to 0.5% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Teicoplanin AptaPharma

Recommended dose:

Adults and children (aged 12 and over) without kidney problems

Infections of the skin and soft tissues, lungs, and urinary tract

• Initial dose (for the first three doses): 6 mg per kilogram of body weight administered every 12 hours by intravenous or intramuscular injection.
• Maintenance dose: 6 mg per kilogram of body weight administered once a day by intravenous or intramuscular injection.

Infections of bones and joints and heart infections

• Initial dose (for the first three to five doses): 12 mg per kilogram of body weight administered every 12 hours by intravenous injection.
• Maintenance dose: 12 mg per kilogram of body weight administered once a day by intravenous or intramuscular injection.

Infection caused by Clostridium difficile
Recommended dose is 100 to 200 mg orally, twice a day for 7 to 14 days.

Adults and elderly patients with kidney problems

If the patient has kidney problems, the dose should usually be reduced after the fourth day of treatment:

• In patients with mild and moderate kidney problems - the maintenance dose will be administered every two days or half of the maintenance dose will be administered once a day.
• In patients with severe kidney problems or undergoing hemodialysis - the maintenance dose will be administered every three days or one-third of the maintenance dose will be administered once a day.

Peritonitis in patients undergoing peritoneal dialysis

Initial dose is 6 mg per kilogram of body weight in a single intravenous injection, and then:

• First week: 20 mg/L in each dialysis bag.
• Second week: 20 mg/L in every other dialysis bag.
• Third week: 20 mg/L in the dialysis bag left overnight.

Newborns and infants (from birth to 2 months)

• Initial dose (on the first day): 16 mg per kilogram of body weight in an intravenous infusion using a drip.
• Maintenance dose: 8 mg per kilogram of body weight administered once a day in an intravenous infusion using a drip.

Children (from 2 months to 12 years)

• Initial dose (for the first three doses): 10 mg per kilogram of body weight, administered every 12 hours, by intravenous injection.
• Maintenance dose: 6 to 10 mg per kilogram of body weight, administered once a day by intravenous injection.

How Teicoplanin AptaPharma is administered

This medicine is usually administered by a doctor or nurse.

• The medicine will be administered by intravenous injection (intravenous administration) or into a muscle (intramuscular administration).
• The medicine can also be administered by intravenous infusion using a drip. In infants from birth to 2 months, only infusion administration should be used. In the treatment of some infections, the solution may be taken orally (oral administration).

Using a higher dose of Teicoplanin AptaPharma than recommended

It is unlikely that the doctor or nurse will administer too high a dose of the medicine. However, if the patient thinks they have received too high a dose of Teicoplanin AptaPharma or if the patient is agitated, they should immediately consult their doctor or nurse.

Missing a dose of Teicoplanin AptaPharma

The doctor or nurse will have instructions on how to administer Teicoplanin AptaPharma to the patient. It is unlikely that they will administer the medicine to the patient in a way that is not in line with the recommendations. However, if the patient has concerns, they should consult their doctor or nurse.

Stopping treatment with Teicoplanin AptaPharma

The patient should not stop using the medicine without first consulting their doctor, pharmacist, or nurse.
If the patient has any further doubts about using this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe side effects

If any of the following severe side effects occur, treatment should be stopped and the patient should immediately consult their doctor or nurse, as they may need urgent medical attention.

Uncommon(may occur in up to 1 in 100 people):

• life-threatening allergic reaction - symptoms may include: difficulty breathing or wheezing, swelling, rash, itching, fever, chills

Rare(may occur in up to 1 in 1,000 people):

• redness of the upper body

Frequency not known(frequency cannot be estimated from the available data):

• blisters on the skin, mouth, eyes, or genitals - these may be symptoms of a condition called "toxic epidermal necrolysis" or "Stevens-Johnson syndrome"
• red, scaly, widespread rash with bumps under the skin (including skin folds, chest, abdomen (including stomach), back, and arms) and blisters with accompanying fever - these may be symptoms of acute generalized exanthematous pustulosis (AGEP)
• drug reaction with eosinophilia and systemic symptoms (DRESS). Initially, DRESS appears as flu-like symptoms and a rash on the face, then as a widespread rash with high fever, increased liver enzyme activity observed in blood tests, and an increase in the number of a certain type of white blood cell (eosinophilia) and lymph node enlargement.

If the patient experiences any of the above side effects, they should immediately inform their doctor or nurse.
If the patient notices any of the following severe side effects, they should immediately inform their doctor or nurse, as they may need urgent medical attention.
Uncommon(may occur in up to 1 in 100 patients):

• swelling and blood clots in a vein
• difficulty breathing or wheezing (bronchospasm)
• more infections than usual - these may be symptoms of a decrease in the number of white blood cells

Frequency not known(frequency cannot be estimated from the available data):

• low white blood cell count (agranulocytosis) - symptoms may include: fever, severe chills, sore throat, or mouth ulcers
• kidney problems or changes in kidney function - visible in tests. When higher doses are administered to the patient, there may be an increased frequency or severity of kidney problems.
• seizures

If the patient experiences any of the above side effects, they should immediately inform their doctor or nurse.

Other side effects

The patient should consult their doctor, pharmacist, or nurse if they experience any of the following side effects:

Common(may occur in up to 1 in 10 patients):

• rash, redness, itching
• pain
• fever

Uncommon(may occur in up to 1 in 100 patients):

• decreased platelet count
• increased liver enzyme activity in the blood
• increased creatinine levels in the blood (monitoring kidney function)
• hearing loss, ringing in the ears, or a feeling that the patient or objects around them are moving
• nausea or vomiting, diarrhea
• dizziness or headache

Rare(may occur in up to 1 in 1,000 patients):

• infection (abscess)

Frequency not known(frequency cannot be estimated from the available data):

• disorders at the injection site - such as redness of the skin, pain, or swelling
• low levels of all types of blood cells

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Teicoplanin AptaPharma

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial label after: EXP. The expiry date refers to the last day of the month stated.
This medicinal product does not require any special storage conditions regarding temperature.
Store in the original packaging to protect from light.
Information on the storage conditions and shelf life of Teicoplanin AptaPharma after reconstitution and preparation for use is given in the section "Practical information on the preparation of Teicoplanin AptaPharma and handling of the medicine intended for healthcare professionals".

6. Contents of the packaging and other information

What Teicoplanin AptaPharma contains

• The active substance of the medicine is teicoplanin. Each vial contains 200 mg or 400 mg of teicoplanin.
• The other ingredients are: sodium chloride and sodium hydroxide (to adjust pH) in the powder; water for injections in the solvent.

What Teicoplanin AptaPharma looks like and what the pack contains

Teicoplanin AptaPharma is a powder and solvent for solution for injection/infusion.
The powder is a spongy, lyophilized powder, white or ivory in color. The solvent is a clear, colorless liquid.
Teicoplanin AptaPharma 200 mg after reconstitution is a slightly brownish, opalescent solution.
Teicoplanin AptaPharma 400 mg after reconstitution is a brownish, opalescent solution.
The powder is packed in:

• a 10 mL glass vial type I, closed with a gray rubber stopper type I and a blue flip-off seal type consisting of an aluminum cap and a polypropylene disc (PP disc).
• a 20 mL glass vial type I, closed with a gray rubber stopper type I and a red flip-off seal type consisting of an aluminum cap and a polypropylene disc (PP disc).

The solvent is placed in an ampoule made of colorless glass type I.
Pack size:

• 1 vial with powder + 1 ampoule with solvent in a carton.
• 10 x (1 vial with powder + 1 ampoule with solvent) in a carton.

Not all pack sizes may be marketed.

Marketing authorization holder

Apta Medica Internacional d.o.o.
Likozarjeva Ulica 6
1000 Ljubljana
Slovenia
Phone: 00386 51 615 015
e-mail: [email protected]

Manufacturer

Sirton Pharmaceuticals S.p.A.
Piazza XX Settembre, 2
22079 Villa Guardia (CO)
Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:

Information intended for healthcare professionals only:

Practical information on the preparation of Teicoplanin AptaPharma and handling of the medicine.

This medicine is intended for single use only.
Method of administration
After reconstitution, the solution can be administered by injection directly or after further dilution.
The medicine will be administered by injection in a bolus over 3-5 minutes or in a 30-minute intravenous infusion.
In infants from birth to 2 months, the medicine should be administered only by intravenous infusion.
After reconstitution, the solution can also be administered orally.
Preparation of the solution:

• Slowly inject the entire contents of the attached solvent into the vial with the powder.
• Gently rotate the vial in the hands until the powder is completely dissolved. If the solution becomes foamy, it should be left to stand for about 15 minutes. After reconstitution, the solutions will contain 200 mg of teicoplanin in 3.0 mL or 400 mg in 3.0 mL.

Only clear and brownish solutions should be used.
The resulting solution is isotonic with plasma and has a pH of 7.2-7.8.

Dilution of the solution before infusion:
Teicoplanin AptaPharma can be administered in the following infusion solutions:

• 9 mg/mL (0.9%) sodium chloride solution
• Ringer's solution
• Ringer's solution with lactate
• 50 mg/mL (5%) dextrose injection solution
• 100 mg/mL (10%) dextrose injection solution
• 1.8 mg/mL (0.18%) sodium chloride solution and 40 mg/mL (4%) glucose solution
• 4.5 mg/mL (0.45%) sodium chloride solution and 50 mg/mL (5%) glucose solution
• peritoneal dialysis solution containing 13.6 mg/mL (1.36%) or 38.6 mg/mL (3.86%) glucose solution.

Shelf life of the solution after reconstitution
The chemical and physical stability of the solution prepared in accordance with the recommendations has been demonstrated for 24 hours at a temperature of 2 to 8°C.
For microbiological reasons, the product should be used immediately. If not used immediately, the storage time and conditions before use are the responsibility of the user and are usually not longer than 24 hours at a temperature of 2 to 8°C.
Shelf life of the medicine after dilution
The chemical and physical stability of the solution prepared in accordance with the recommendations has been demonstrated for 24 hours at a temperature of 2 to 8°C.
For microbiological reasons, the product should be used immediately. If not used immediately, the storage time and conditions before use are the responsibility of the user and are usually not longer than 24 hours at a temperature of 2 to 8°C.
Disposal
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.